Abstract:
:he concept of particulates, while common to many in the pharmaceutical and blood transfusion disciplines, represents a distinct challenge in the field of cellular therapy. With newly discovered products advancing through clinical trials, the focus has shifted to ensuring products are manufactured in a reliable and safe manner. Given the unique manufacturing processes and resulting products (i.e. the cell being the active ingredient of the product), the way in which particulates are viewed and subsequently tested needs to be reviewed. No specific test or method for particulates will apply to all products, and guidance documents will be generated over time as more cell therapy products are approved. The details of the processes, testing methods used and acceptance criteria established for particulates will play a major role in generating the guidance documents. This will ultimately allow for the manufacture and administration of safe and effective products without thwarting advancement of the cellular therapy field. The intent of this review is to bring awareness to the topic of particulates with respect to cell therapy, and encourage a more open dialog and exchange of examples within the industry. We have reviewed the concept of particulates, where they originate and how they are introduced to cell therapy products, and the current methods available for their detection. We have also reviewed the relevance of current guidance documents and present potential strategies to move forward and address and control unwanted contaminating particulates in cell therapy products.
journal_name
Cytotherapyjournal_title
Cytotherapyauthors
Clarke D,Harati D,Martin J,Rowley J,Keller J,McCaman M,Carrion M,Karnieli O,Maziarz R,Perry R,Oh S,Stanton Jdoi
10.3109/14653249.2012.706709subject
Has Abstractpub_date
2012-10-01 00:00:00pages
1032-40issue
9eissn
1465-3249issn
1477-2566pii
S1465-3249(12)71222-7journal_volume
14pub_type
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